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CompletedNCT04088552Updated Oct 20, 2021

Preventing Chronic Disease: ActuaYa

An interventional study of Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 and ActuaYa Educational Sessions in Healthy Aging, sponsored by University of Miami. Completed at 1 site in United States. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by University of Miami · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
50 Years and older
Sex
Female
01

Study summary

The purpose of the study is to help older Hispanic women to increase physical activity, reach a healthy body weight, increase self-esteem and mood and increase knowledge about chronic diseases such as hypertension, diabetes, and HIV.

02

Conditions studied

  • Healthy Aging

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03

In context

Chronic Disease

990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.

This study's enrollment of 50 is below the median of 120 across 722 interventional studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Must self-identify as a Hispanic woman
  2. Must be aged 50 years or older
  3. Must not already be engaging in exercise for >150 minutes per week
  4. Must be able to ambulate without the use of assistive devices
  5. Must have an intelligent phone iOS or Android
  6. Must be willing and able to participate in the informed consent process.

Exclusion criteria

Exclusion Criteria

  1. Participants that do not meet the above-mentioned criteria.
  2. In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate.
  3. Participants who are currently participating in another investigational study.
  4. Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    ActuaYa Arm

    Participants will receive educational sessions, facilitated discussions and an exercise program.

    Other: Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 · Behavioral: ActuaYa Educational Sessions

Interventions

  • OtherGo4Life-Physical Activity/Exercise Program "Workout to Go" 5

    The Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 Program is an exercise regimen provided to participants. Participants will be provided a booklet with exercise routines that requires minimal equipment and can be performed anywhere for approximately 30 minutes per session. Recommendation on staying active by increasing daily steps through walking will also be recommended as part of the regimen.

  • BehavioralActuaYa Educational Sessions

    The ActuaYa Educational Sessions will be delivered by a facilitator in 3 separate sessions with each session lasting 2.5 hours for a total of 7.5 hours administered for the study duration. Each session will be conducted in separate groups of 6-10 participants. Session 1 will discuss the impact of chronic disease in the older Hispanic community. Session 2 will discuss the communication and negotiation with the family and partner. Session 3 will discuss saying goodbye and having a plan for a healthy lifestyle.

06

What researchers measure

Primary outcomes

  1. Change in mean Hemoglobin A1C (HbA1c) levels

    HbA1c will be measured from finger stick blood sample.

    Time frame: Baseline, 6 months

  2. Change in Blood Pressure

    Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.

    Time frame: Baseline, 6 months

  3. Change in Body Mass Index (BMI)

    BMI will be measured by weight and height using the formula: 703 multiplied by the weight in lbs divided by the square of height in inches.

    Time frame: Baseline, 6 months

  4. Change in self-efficacy for condom use

    Measured using the HIV self-efficacy for condom use survey. Scores range from 7-28. A higher score indicates a higher level of self-efficacy for condom use.

    Time frame: Baseline, 6 months

  5. Change in nutritional habits

    Change in nutritional habits will be evaluated via the Healthy Eating Index (HEI) using the self-reported data from the nutrition survey. The HEI scores range from 0 to 100 with a higher score indicating healthier eating habits with food intake aligning with key dietary recommendations from the Dietary Guidelines for Americans.

    Time frame: Baseline, 6 months

  6. Change in active lifestyle as assessed by daily steps

    Change in active lifestyle will be assessed by the amount of daily steps taken as assessed using a study provided wrist pedometer.

    Time frame: Baseline, 6 months

  7. Change in active lifestyle as assessed by a self-report log

    Change in active lifestyle will be assessed by the number of days per week the participant completed the recommended 30-minutes exercise via a self-report log.

    Time frame: Baseline, 6 months

  8. Change in active lifestyle as assessed by the Exercise Survey

    Change in active lifestyle will be assessed using the Exercise Survey. The exercise survey is a 19-item survey with each item having a score ranging from 0-10. A higher total score indicates a higher level of physical activity.

    Time frame: Baseline, 6 months

  9. Change in active lifestyle as assessed by the Exercise Question Survey

    Change in active lifestyle will be assessed using the Exercise Question Survey. The exercise survey is a 9-item survey with total score ranging from 0-90. A higher total score indicates a higher level of physical activity.

    Time frame: Baseline, 6 months

  10. Change in HIV risk behaviors

    Change in HIV risk behaviors will be assessed using the Partner Table Survey. The Partner Table Survey is a 5-item survey with a total score ranging from 1-17 with a higher score indicating a higher HIV risk behavior.

    Time frame: Baseline, 6 months

  11. Change in body fat composition

    Measured using a bioelectrical impedance analysis.

    Time frame: Baseline, 6 months

  12. Change in abdominal circumference

    Measured using a measuring tape.

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Change in knowledge regarding obesity

    Change in knowledge regarding obesity will be measured using the obesity knowledge and risk perception questionnaire. For obesity knowledge, the scores range from 6-12. A higher score indicates a lower level of obesity-related knowledge.

    Time frame: Baseline, 6 months

  2. Change in risk perception regarding obesity

    Change in risk perception regarding obesity will be measured using the obesity knowledge and risk perception questionnaire. For obesity risk perception, the scores range from 3-9. A higher score indicates a lower level of obesity risk perception.

    Time frame: Baseline, 6 months

  3. Change in knowledge regarding diabetes

    Change in diabetes knowledge will be measured using the Diabetes Knowledge Questionnaire (DKQ-24). It is a 24 item questionnaire wherein a score of 17 or more correct responses indicate sufficient diabetes knowledge and a score of 6 or less correct responses indicate insufficient diabetes knowledge.

    Time frame: Baseline, 6 months

  4. Change in HIV knowledge

    Change in HIV knowledge will be measured via the HIV Knowledge Scale. The score ranges from 0-12 with a higher score indicating a higher level of HIV-related knowledge.

    Time frame: Baseline, 6 months

  5. Change in HIV risk perception

    Change in HIV risk perception will be measured via the HIV Risk Perception Scale. The total score ranges from 4-14 with a higher score indicating a higher level of HIV-related knowledge.

    Time frame: Baseline, 6 months

  6. Change in self-esteem

    Change in self-esteem will be measured by the Rosenberg Self-Esteem Scale via interview. The total score ranges from 0 to 30 with a score of 14 and less indicating low self-esteem.

    Time frame: Baseline, 6 months

  7. Change in depressive symptoms as assessed by the CES-D20

    Change in depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D20). The CES-D20 has a total score ranging from 0 to 60 with a higher score indicating greater depressive symptoms.

    Time frame: Baseline, 6 months

  8. Change in depressive symptoms as assessed by the GDS

    Change in depressive symptoms will be measured using the Geriatric Depression Scale (GDS). The GDS has a total score ranging from 0-15 with a higher score indicating higher depressive symptoms. A score of 6 to 9 indicates suggestive depressive symptoms and a score of 10 to 15 indicates depressive symptoms.

    Time frame: Baseline, 6 months

  9. Change in health care related habits

    Change in healthcare related habits is measured via the Health Care-Related Factors Questionnaire. The total score ranges from 26 to 43 with a higher score indicating lesser health care related habits.

    Time frame: Baseline, 6 months

  10. Change in technology use

    Change in technology use will be measured using a questionnaire assessing ability to use technology (pedometer, smartphones, apps, internet). The total score ranges from 13-26 with a higher score indicating a lower ability to use technology.

    Time frame: Baseline, 6 months

  11. Change in knowledge regarding hypertension

    Change in knowledge regarding hypertension is measured using the Hypertension Survey. The Hypertension Survey is a 10-item survey with a totals score ranging from 0-10 with a higher score indicating increased knowledge regarding hypertension.

    Time frame: Baseline, 6 months

07

Study locations

1 site
  • University of Miami
    Miami, Florida 33146, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04088552
Lead sponsor
University of Miami
Collaborators
The Community Foundation of Broward
Responsible party
Rosina Cianelli (Associate Professor, University of Miami) — Principal investigator
First posted
Sep 13, 2019
Start date
Mar 7, 2020
Primary completion
Sep 29, 2021
Completion
Sep 29, 2021
Last update
Oct 20, 2021

Study contacts

Rosina Cianelli, Ph.D.
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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